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老年心肌梗死患者体力活动干预 (PIpELINe)

2026年11月4日 更新者:Gianluca Campo、University Hospital of Ferrara

早期、量身定制的身体活动干预对老年心肌梗死患者的有效性:PIpELINe 随机临床试验

Elderly patients presenting with myocardial infarction (MI) are the highest risk population with the worst prognosis. No trial has ever been designed to optimize their outcome through a systematic improvement of their physical performance. Cardiac rehabilitation demonstrated to improve prognosis of patients after MI. However, real-life data shows that older patients are not referred to rehabilitation centers or they have low rate of attendance because of the high number of rehabilitation sessions and of logistic problems. So, data about effectiveness of rehabilitation programs in older MI patients is lacking.

The "Physical Activity Intervention for Elderly Patients with Reduced Physical Performance after acute coronary syndrome (HULK)" pilot study (NCT03021044) enrolled older MI patients and it demonstrated the feasibility and effectiveness of an early, tailored and low-cost physical activity intervention in terms of physical performance assessed by Short Physical Performance Battery (SPPB) score, that is strongly related to prognosis. The HULK study was focused on exercise training and not powered for hard endpoints. If a multi-domain lifestyle intervention in an adequately powered study may further improve prognosis is unknown. Thus, the investigator's hypothesis for the PIpELINe trial is that an early, tailored and low-cost multi-domain lifestyle intervention may improve prognosis of older MI patients compared to health education alone. The primary outcome is a composite of 1-year cardiovascular death and hospital readmission for cardiovascular cause.

研究概览

详细说明

The PIpELINe trial will include older MI patients. All patients aged 65 years and older undergoing coronary angiography because of MI must be screened for eligibility. Patient's eligibility must be assessed after percutaneous revascularization of all lesions considered susceptible of treatment. After verifying inclusion and exclusion criteria and after eligibility is confirmed, written informed consent must be obtained prior to randomization. At the time of the discharge (T0) SPPB test will be performed; in case of a score between 4 and 9, the patient will be evaluated 1-month after discharge at the inclusion visit (T1). If SPPB value is confirmed to be between 4 and 9, randomization will be performed. Key baseline patient characteristics (i.e., inclusion/exclusion criteria, demographics, medical history, details of cardiovascular anatomy and of revascularization, ECG and laboratory test results, echocardiographic data during the index hospitalization) will be recorded on the electronic Case Report Forms (eCRF). All angiographic and echocardiographic data will be collected and forwarded to a core lab for further assessment.

Randomization will be performed during the inclusion visit (T1), 30 days after discharge. Randomization will be performed centrally using an internet-based system. The patient identification number (Patient ID) and the treatment allocation will be assigned by the central randomization system. Patients will be randomized to physical activity group or health education group by a 2:1 allocation. Treatment allocation will be assigned according to a computer-generated randomization list stratified by center. All randomized patients are irrevocably in the study, whether or not they are subsequently found to be eligible, or actually receiving the allocated treatment. Therefore, all patients must be followed until the pre-specified study end date.

The aim of the study is to demonstrate that the proposed multi-domain lifestyle intervention reduces the composite endpoint of cardiovascular death and hospital readmission for cardiovascular cause. The primary endpoint is at 1 year. The follow-up will be extended up to 2 and 3 years.

The protocol includes 3 pre-specified substudies. The possibility to participate in the substudy is left to patient's decision and doesn't preclude the procedures of the main protocol.

  • Anxiety and depression: previous studies reported an association between cardiovascular events and a subsequent appearance of mood disorders which could determine a lack in following secondary prevention recommendations. No data is available about these disorders in older adults. In order to assess depression after MI in older patients and the effect of physical activity intervention on mood disorders, this sub-study will be performed.
  • Mitochondrial function: in both study groups the mitochondrial functional are investigated starting from blood samples and skin biopsy. Skin biopsy is performed to obtain fibroblasts. In-vitro assessment of the mitochondrial function is done on the fibroblasts of patients. The parameters obtained are related with the effectiveness of physical intervention and with the benefit obtained. A total of at least 30 patients is required.
  • Lymphocyte and miRNA activity: taking into account the immunosenescence and the benefits of physical activity on the immune system, this sub-study aims to obtain data regarding T-lymphocyte function in older adults and to assess the effect of physical activity intervention on the function of the different groups of T-lymphocyte. Analyses of physical activity effects on micro ribonucleic acids (miRNAs) are also performed.

研究类型

介入性

注册 (实际的)

512

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Bologna、意大利
        • UO Cardiologia, Ospedale Maggiore
      • Ferrara、意大利
        • Cardiology Unit
      • Lagosanto、意大利
        • Cardiologia Riabilitativa, AUSL d Ferrara
      • Piacenza、意大利
        • Medicina dello Sport, AUSL Piacenza
    • BO
      • Bologna、BO、意大利
        • Medicina dello Sport SSD
    • FE
      • Ferrara、FE、意大利
        • Centro Studi Biomedici applicati allo Sport, Ferrara
    • PC
      • Piacenza、PC、意大利
        • Ospedale Guglielmo da Saliceto, Piacenza

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 及以上 (年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients ≥65 years
  • Hospital admission for myocardial infarction
  • Invasive management during index hospitalization including coronary artery angiography (± percutaneous coronary revascularization)
  • SPPB value 4-9 at 1-month visit after hospital discharge
  • Informed consent

Exclusion Criteria:

  1. Multivessel coronary artery disease or left main coronary artery disease candidate to surgical revascularization
  2. Planned staged percutaneous coronary intervention (PCI)
  3. Non-cardiovascular co-morbidity reducing life expectancy to < 1 year
  4. Any factor precluding 1-year follow-up
  5. Severe aortic or mitral disease
  6. Ejection fraction <30%
  7. Chronic heart failure New York Heart Association (NYHA) III-IV
  8. Severe cognitive impairment (SPMSQ <4)
  9. Impossibility to do physical activity due to physical impairment

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Health Education

All patients randomized to health education received a single in-person visit, one month post discharge, which included a 30-minute counselling session, supported by educational materials and tailoring of the medical treatment. The educational material provided standardized recommendations on diet, smoking cessation, and physical activity. Quality of life, functional capacity and home physical activity are assessed by proper tools.

Current gold standard in older patients admitted to hospital for MI. The group will receive a 20-minute session with one of the study physicians. Both the patient and relatives will attend these sessions. The study physician will stress the major issues related to a heart-healthy lifestyle and will explain the importance of PA as a powerful and independent factor to improve cardiovascular health and minimize cardiovascular risk. A detailed brochure explaining the benefits of physical activity will be provided to all patients

实验性的:Multi-domain lifestyle intervention

All patients randomized to experimental arm will receive diet counselling, aggressive control of CV risk factors, smoke cessation program and exercise training. The physical activity (PA) intervention will start the program with a supervised PA session immediately after the inclusion visit. Quality of life, functional capacity and daily activities will be assessed by proper tools. The program provides 6 supervised PA sessions (30, 60, 90, 180, 270 and 360 days after hospital discharge [T0]). At the end of each supervised session, calisthenics exercises derived from Otago Exercise Program are prescribed.

The intervention includes diet counselling, smoke cessation program, aggressive CV risk control and PA intervention. The PA intervention consisted of supervised sessions combined with an individualized home-based PA program. Centre-based sessions will be supervised by a sports physician and a nurse, and will take approximately 30 to 40 minutes, including a moderate standardized treadmill-walk, and strength and balance exercises. Based on the practice sessions, patients will receive a walking program to perform at home, unsupervised. The PA programs will be individualized, and consistent with current international recommendations. A selection of calisthenic exercises will be prescribed. Participants will be encouraged to perform the exercises three times per week (approximately 20 minutes). Adjustment of the type and intensity of the home-based PA regimen will be made at each visit. The PA program will be extensively described to the patient and family members.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Cumulative occurrence of cardiovascular death and hospital readmission for cardiovascular cause
大体时间:1-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of 1-year composite endpoint of cardiovascular death plus hospital readmission for cardiovascular cause.

1-year

次要结果测量

结果测量
措施说明
大体时间
Cumulative occurrence of all-cause death
大体时间:1-year

To test the superiority of the early and tailored physical activity intervention over the health education alone in terms of all-cause death

1-year
Cumulative occurrence of all-cause death
大体时间:3-year

To test the superiority of the early and tailored physical activity intervention over the health education alone in terms of all-cause death

3-year
Cumulative occurrence of cardiovascular death
大体时间:1-year

To test the superiority of the early and tailored physical activity intervention over the health education alone in terms of cardiovascular death

1-year
Cumulative occurrence of cardiovascular death
大体时间:3-year

To test the superiority of the early and tailored physical activity intervention over the health education alone in terms of cardiovascular death

3-year
Cumulative occurrence of hospital readmission for cardiovascular cause
大体时间:1-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for cardiovascular cause.

1-year
Cumulative occurrence of hospital readmission for cardiovascular cause
大体时间:3-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of composite endpoint of hospital readmission for cardiovascular cause.

3-year
Cumulative occurrence of cardiovascular death and hospital readmission for cardiovascular cause
大体时间:3-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of composite endpoint of cardiovascular death plus hospital readmission for cardiovascular cause.

3-year
Cumulative occurrence of hospital readmission for heart failure
大体时间:1-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for heart failure

1-year
Cumulative occurrence of hospital readmission for heart failure
大体时间:3-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for heart failure

3-year
Cumulative occurrence of hospital readmission for myocardial infarction
大体时间:1-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for myocardial infarction

1-year
Cumulative occurrence of hospital readmission for myocardial infarction
大体时间:3-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for myocardial infarction

3-year
Cumulative occurrence of hospital readmission for coronary revascularization
大体时间:1-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for coronary revascularization

1-year
Cumulative occurrence of hospital readmission for coronary revascularization
大体时间:3-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for coronary revascularization

3-year
Cumulative occurrence of cerebrovascular accident
大体时间:1-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of cerebrovascular accident

1-year
Cumulative occurrence of cerebrovascular accident
大体时间:3-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of cerebrovascular accident

3-year
Cumulative occurrence of hospital readmission for any cause
大体时间:1-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for any cause

1-year
Cumulative occurrence of hospital readmission for any cause
大体时间:3-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for any cause

3-year
Cumulative occurrence of hospital readmission for any non-cardiovascular cause
大体时间:1-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for any non-cardiovascular cause

1-year
Cumulative occurrence of hospital readmission for any non-cardiovascular cause
大体时间:3-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for any non-cardiovascular cause

3-year
Cumulative occurrence of bleeding adverse events
大体时间:1-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of bleeding adverse events

1-year
Cumulative occurrence of bleeding adverse events
大体时间:3-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of bleeding adverse events

3-year

其他结果措施

结果测量
措施说明
大体时间
Short Physical Performance Battery
大体时间:6-month

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of physical performance (SPPB ranges from 0 to 12, higher values mean better physical performance)

6-month
Short Physical Performance Battery
大体时间:1-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of physical performance (SPPB ranges from 0 to 12, higher values mean better physical performance)

1-year
Short Physical Performance Battery
大体时间:3-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of physical performance (SPPB ranges from 0 to 12, higher values mean better physical performance)

3-year
Handgrip strength
大体时间:6-month

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of physical performance (handgrip strength, ranges from 0 to infinity, higher values mean better physical performance)

6-month
Handgrip strength
大体时间:1-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of physical performance (handgrip strength, ranges from 0 to infinity, higher values mean better physical performance)

1-year
Handgrip strength
大体时间:3-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of physical performance (handgrip strength, ranges from 0 to infinity, higher values mean better physical performance)

3-year
Gait speed
大体时间:6-month

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of physical performance (10 meters gait speed ranges from 0 to infinity, higher values mean better physical performance)

6-month
Gait speed
大体时间:1-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of physical performance (10 meters gait speed ranges from 0 to infinity, higher values mean better physical performance)

1-year
Gait speed
大体时间:3-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of physical performance (10 meters gait speed ranges from 0 to infinity, higher values mean better physical performance)

3-year
EQ5D visual analogue scale
大体时间:6-month

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of quality of life (EQ5D VAS points)

6-month
EQ5D visual analogue scale
大体时间:1-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of quality of life (EQ5D VAS points)

1-year
EQ5D visual analogue scale
大体时间:3-year

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of quality of life (EQ5D VAS points)

3-year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年3月27日

初级完成 (实际的)

2024年11月30日

研究完成 (实际的)

2026年11月4日

研究注册日期

首次提交

2019年11月27日

首先提交符合 QC 标准的

2019年12月2日

首次发布 (实际的)

2019年12月3日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月4日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 共享时间框架

After publication of the main findings

IPD 共享访问标准

It will be necessary a formal request to the Executive Committee of the study. The request will be analyzed and considered for acceptance

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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